A cloud based end-to-end metadata repository

About

Clinical Metadata is a web-based metadata management solution that helps the pharmaceutical industry implement CDISC standards and accelerates the study reporting process.

The tool manages raw, SDTM, ADaM and Analysis Results Metadata, steers users towards CDISC compliance and generates SAS code fragments and submission deliverables. It assists the standards governance process by managing metadata across a standards hierarchy, promoting metadata re-use and saving user time.

Built using the latest enterprise grade technologies, and with a focus on security, transparency and traceability, Clinical Metadata is intuitive to use and promotes collaborative working.

Clinical Metadata is designed and built by a UK team based in London and Warwickshire.


Features

Using the latest technologies to simplify clinical metadata management

Clinical trial metadata management

  • End-to-end clinical trial meadata management
  • Raw/ CDASH metadata
  • SDTM metadata
  • ADaM metadata
  • Analysis Results Metadata
  • Mock-ups

Standards management

  • CDISC Foundational and TA standards
  • Store metadata within a user defined standards hierarchy
  • Exchange metadata across a hierarchy

Submission deliverables

  • Automatically create Define.xml version 2
  • Ensure alignment between Define.xml and study metadata

Metadata-driven code generation

  • Generate SAS code fragments directly from the metadata
  • Automates repetitive programming
  • Ensure alignment between programming and metadata

Traceability

  • Impact analysis
  • Metadata visualisations from CRF-> Raw->SDTM->ADaM->Output
  • Version control
  • Audit trail

Technology

  • Securely hosted on the Amazon Web Services (AWS) cloud
  • Built using enterprise grade technologies
  • Developed according to Agile methodologies

Project management tools

  • Inbuilt communication tools
  • Status tracking of individual programming deliverables
  • High level summary of study status

User-focus

  • Built around the principles of traceability and transparency
  • Checks for common CDISC compliance issues at data entry
  • Easy to learn and intuitive to use

Data exchange

  • Input and output from Define.xml and Microsoft Excel

Contact

Get in touch to find out more or arrange a demo